|
|
||
| 序 文 | iii | 竹内正弘（Masahiro Takeuchi） Stephen W. Lagakos |
| Faculty Members | iv-xix | |
| Program | xx-xxvii | |
| Opening Remarks | 1-2 | 柴 忠義（Tadayoshi Shiba） |
| Congratulatory Remarks | 3-4 | 川原 章（Akira Kawahara） |
| Welcoming Address | 5-6 | Declan P. Doogan |
| Session 1 : Performance of New Drug Research and Development in Japan and its International Competitiveness | 7-70 | Chairperson: Declan P. Doogan |
| Clinical Research to be Delivered to Patients | 9-17 | 笹月健彦（Takehiko Sasazuki） |
| Japanese Pharmacutical Industry from the Viewpoint of National Policy | 19-28 | 渡邉 徹（Toru Watanabe） |
| International Competitiveness of the Japanese Pharmaceutical Industry | 29-35 | 小田切宏之（Hiroyuki Odagiri） |
| The Plan for Promotion of Biotechnology as a Science Technology in Industry | 37-44 | 多喜田圭二（Keiji Takita) |
| International Competitiveness of the Japanese Clinical Trials on Cost and Performance | 45-58 | 島谷克義（Katsuyoshi Shimatani） |
| Panel Discussion | 59-70 | |
| Session 2 : New Challenges-Enhancement of Productivity and Performance- | 71-118 | Chairperson: 井村裕夫（Hiroo Imura） |
| The Impact of Critical Path Initiative on R&D in Japan | 73-83 | 竹内正弘（Masahiro Takeuchi） |
| The Development and Use of Translational Models and Biomarkers in Clinical Development of New Medicines | 85-99 | Jeremy Gale |
| Innovation of Web-based Registration System for an International Collaboration Study on Clear Cell Carcinoma of the Ovary | 101-8 | 藤原恵一(Keiichi Fujiwara） |
| Panel Discussion | 109-18 | |
| Session 3 : New Challenges-Disease Areas- | 119-57 | Chairperson: 高久史麿（Fumimaro Takaku) |
| Vaccination Therapy for Alzheimer's Disease | 121-9 | 田平 武（Takeshi Tabira) |
| Prevention of Cardiovascular Diseases: Aggresive Management of Cardiovascular Risk Factors | 131-40 | 山田信博（Nobuhiro Yamada) |
| Investigator Initiated Trial (IIT): Future for IIT from the Past Experience | 141-6 | 寺岡 あきら(Akira Teraoka) |
| Panel Discussion | 147-57 | |
| Session 4 : New Challenges-Innovative Study Design, along with Mathematical Approch and Simulation of Global/Regional Clinical Studies- | 159-215 | Chairperson: Marvin Zelen |
| Design Considerations in Global Clinical Trials: Keys in Newly Disigning of Global Studies and Validation Study Designs of Novel Biomarkers | 161-6 | H.M. James Hung |
| Design Issues in Anti-infective Trials: Opportunities and Challenges for Innovative Study Designs | 167-74 | Daphne Lin |
| Explore and Develop Modeling/Simulation: "RALES" Design Kitasato-Harvard-Pfizer-Hitachi Project | 175-89 | 宇野 一（Hajime Uno) |
| Data Mining Approach to Improve the Accuracy of AE Analysis: Establishment of Key Medical Institute Network, Collection of AE Information and its Analysis | 191-7 | 小島千枝（Chie Kojima) |
| Panel Discussion | 199-215 | |
| Session 5 : Regulatory-based Dialogues-Global Trials, Asian Trials- | 217-85 | Chairperson: 竹内正弘(Masahiro Takeuchi) |
| A Trial to Assess Ethnicity and Hint on How to Design Global/Asian Studies | 219-32 | Keith D. Wilner |
| Regulatory Aspect of Asian Trials Regulatory-based Dialogues in Taiwan for Global and Asian Trials | 233-8 | Herng-Der Chern |
| Regulatory Perspectives and Clinical Trial Situation in Korea | 239-44 | In-Jing Jang |
| Regulatory-based Dialogues: Regulatory Aspect of Asian Trials | 245-55 | Yang-Tong Foo |
| Regulatory Aspect of Asian Trials: Whither (and Whether) Bridging? | 257-63 | 小林 健(Ken Kobayashi) |
| Challenge of a Global Trial and an Asian Trial | 265-74 | 仁平新一(Shin-ichi Nihira) |
| Panel Discussion | 275-85 | |
| Session 6 : Regulatory-based Dialogues-Performance of Regulatory Review- | 287-333 | Chairperson: 小野俊介（Shunsuke Ono） |
| Opening Remarks at Session 6 | 289-90 | 小野俊介（Shunsuke Ono） |
| Current Status and Future Perspectives of Clinical Trial Consultation and NDA Review Performance | 291-9 | 宇山佳明（Yoshiaki Uyama）/TD> |
| Proposal from industry eg. Quality, Performance and Training | 301-6 | 高橋希人（Kihito Takahashi） |
| Review System for NDA Approval in the USA and Japan and their Performance of Review | 307-14 | 安積織衛（Orie Asaka） |
| Eary Approval and Launch of New Drugs: Dissolution of Drug Lag | 315-9 | 成川 衛（Mamoru Narukawa） |
| Panel Discussion | 321-33 | |
| Conclusion & Closing Remarks | 335-42 | |
| Conclusion | 337-40 | Lee-Jen Wei |
| Closing Remarks | 341-2 | 竹内正弘（Masahiro Takeuchi） |